Breast AugmentationNCT01853605

NATRELLE® 410 Full and Moderate Height/Projection Breast Implant Continued Access Post-Approval Study

A study testing Anatomically shaped silicone gel-filled breast implants in people with Breast Augmentation and Breast Reconstruction, run by Allergan at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Post-approval study of the safety and effectiveness of NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Styles 410 FM, FF, MM, or MF) for breast augmentation, reconstruction, or revision Read more about this study

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Breast Augmentation, Breast Reconstruction, Breast Implant Revision
What is being tested?: Anatomically shaped silicone gel-filled breast implants
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3,811 participants
Where: 1 siteUnited States
Study dates: Apr 2003to Aug 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

For entry in this study, subjects must have been enrolled in the 410 CA Clinical Study or 410 CARE Clinical Study under the inclusion criteria listed below and received NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants Styles 410 FM, FF, MM, or MF in 1 (for unilateral breast reconstruction or revision) or both breasts.
Female, age 18 or older
Present with one or more of the following conditions:
Primary breast augmentation (i.e., no previous breast implant surgery) indicated for subject dissatisfaction, with size or shape of breast (e.g., mammary hypoplasia), asymmetry, ptosis, or aplasia
Primary breast reconstruction (i.e., no previous breast implant surgery other than implantation of tissue expanders or contralateral augmentation for asymmetry) indicated, in the affected breast, for mastectomy for cancer, prophylactic mastectomy, or breast trauma (resulting in mastectomy) and for the unaffected breast, contralateral asymmetry (may be performed on the date of the mastectomy or the date when permanent implants are placed in the reconstructed breast)
Breast implant revision surgery (i.e., removal and replacement of breast implants) indicated for previous augmentation or reconstruction with silicone-filled or saline-filled breast implants
Has adequate tissue available to cover implants
Willing to undergo MRI at the specified follow-up visit for subjects at MRI designated sites and be eligible for MRI (e.g., no implanted metal or metal devices, no history of severe claustrophobia)

Who cannot join

For entry in this study, subjects must have been enrolled in the 410 CA Clinical Study or 410 CARE Clinical Study and met the exclusion criteria listed below but not received any NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled 410 X- or L-Style Breast Implants
Does not have advanced fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy
Does not have existing carcinoma of the breast, without mastectomy
Does not have abscess or infection in the body at the time of enrollment
Is not pregnant or nursing
Does not have any disease, including uncontrolled diabetes (e.g., HbA1c > 8%), that is clinically known to impact wound healing ability

Show all 10Show fewer

Does not show tissue characteristics that are clinically incompatible with mammaplasty, such as tissue damage resulting from radiation, inadequate tissue, compromised vascularity, or ulceration
Does not have or is under treatment for any condition that may constitute an unwarranted surgical risk (e.g., unstable cardiac or pulmonary problems)
Does not show psychological characteristics that may be incompatible with the surgical procedure and the prosthesis, such as inappropriate attitude or motivation (e.g., body dysmorphic disorder)
Is not willing to undergo further surgery for revision, if medically required

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Eugene, Oregon

Other trials in United States

About this study

Conditions: Breast Augmentation, Breast Reconstruction, Breast Implant Revision
Being tested: Anatomically shaped silicone gel-filled breast implants

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Anatomically shaped silicone gel-filled breast implantsDevice
Also called NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Styles 410 FM, FF, MM, or MF)
Surgical implant

Study groups in NCT01853605
Study group	Role	What they receive
Augmentation	Experimental	Women undergoing breast augmentation. Receives: Device: Anatomically shaped silicone gel-filled breast implants
Reconstruction	Experimental	Women undergoing breast reconstruction. Receives: Device: Anatomically shaped silicone gel-filled breast implants
Revision-Augmentation	Experimental	Women undergoing revision of previous breast augmentation. Receives: Device: Anatomically shaped silicone gel-filled breast implants
Revision-Reconstruction	Experimental	Women undergoing revision of previous breast reconstruction. Receives: Device: Anatomically shaped silicone gel-filled breast implants

What is being measured

The primary outcome is the main question the study is designed to answer.

Subject Satisfaction With Breast Implants on a 5-Point Scale
Subject satisfaction with each breast implant is assessed on the following 5-point scale: (Definitely Satisfied, Somewhat Satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, and Definitely Dissatisfied). Satisfaction is reported for subject's assessing satisfaction as definitely satisfied and somewhat satisfied. The worst response is used if the subject reports different responses for the left and right breasts.
Measured: 5 years
Investigator Satisfaction With Breast Implants on a 5-Point Scale
Investigator satisfaction with each breast implant is assessed on the following 5-point scale: (Definitely Satisfied, Somewhat Satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, and Definitely Dissatisfied). Satisfaction is reported for Investigator's assessing satisfaction as definitely satisfied and somewhat satisfied. The worst response is used if the Investigator reports different responses for the left and right breasts.
Measured: 5 years
Local Complications
Local complications are the cumulative complications occurring in at least 5% of subjects in 1 or more cohorts over the duration of the study. The Kaplan-Meier risk rate is presented.
Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2003Aug 2014

First posted15 May 2013 (estimated)
Study startApr 2003
Primary completionAug 2014
Study completionAug 2014

Why it stopped: The study was discontinued following product approval.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Breast AugmentationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 3,811 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01853605
Sponsor's protocol ID: 410CA-002
Status last verified: Jul 2015
First submitted: 13 May 2013
Last updated: 11 Aug 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
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Effect of Adding Ultrasound-Guided PECS II Block to Standard Multimodal Analgesia in Breast Augmentation Surgery
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Active, not recruitingObservational study
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All Breast Augmentation trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: NATRELLE® 410 Full and Moderate Height/Projection Breast Implant Continued Access Post-Approval Study
ClinicalTrials.gov ID: NCT01853605
Acronym / sponsor ID: 410CA-002
Conditions: Breast Augmentation, Breast Reconstruction, Breast Implant Revision
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was discontinued following product approval.
Enrolment: 3,811 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Apr 2003
Primary completion: Aug 2014 (actual)
Study completion: Aug 2014 (actual)
First posted: 15 May 2013 (estimated)
Results: Posted 11 Aug 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Augmentation	Experimental	Device: Anatomically shaped silicone gel-filled breast implantsWomen undergoing breast augmentation.
Reconstruction	Experimental	Device: Anatomically shaped silicone gel-filled breast implantsWomen undergoing breast reconstruction.
Revision-Augmentation	Experimental	Device: Anatomically shaped silicone gel-filled breast implantsWomen undergoing revision of previous breast augmentation.
Revision-Reconstruction	Experimental	Device: Anatomically shaped silicone gel-filled breast implantsWomen undergoing revision of previous breast reconstruction.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

For entry in this study, subjects must have been enrolled in the 410 CA Clinical Study or 410 CARE Clinical Study under the inclusion criteria listed below and received NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants Styles 410 FM, FF, MM, or MF in 1 (for unilateral breast reconstruction or revision) or both breasts.
Female, age 18 or older
Present with one or more of the following conditions:
Primary breast augmentation (i.e., no previous breast implant surgery) indicated for subject dissatisfaction, with size or shape of breast (e.g., mammary hypoplasia), asymmetry, ptosis, or aplasia
Primary breast reconstruction (i.e., no previous breast implant surgery other than implantation of tissue expanders or contralateral augmentation for asymmetry) indicated, in the affected breast, for mastectomy for cancer, prophylactic mastectomy, or breast trauma (resulting in mastectomy) and for the unaffected breast, contralateral asymmetry (may be performed on the date of the mastectomy or the date when permanent implants are placed in the reconstructed breast)

Key exclusion criteria (10 listed)

For entry in this study, subjects must have been enrolled in the 410 CA Clinical Study or 410 CARE Clinical Study and met the exclusion criteria listed below but not received any NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled 410 X- or L-Style Breast Implants
Does not have advanced fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy
Does not have existing carcinoma of the breast, without mastectomy
Does not have abscess or infection in the body at the time of enrollment
Is not pregnant or nursing

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Anatomically shaped silicone gel-filled breast implantsAlso: NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Styles 410 FM, FF, MM, or MF)Surgical implant	Device	Augmentation, Reconstruction, Revision-Augmentation, Revision-Reconstruction

Primary outcome

Subject Satisfaction With Breast Implants on a 5-Point Scale
Time frame: 5 years
Subject satisfaction with each breast implant is assessed on the following 5-point scale: (Definitely Satisfied, Somewhat Satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, and Definitely Dissatisfied). Satisfaction is reported for subject's assessing satisfaction as definitely satisfied and somewhat satisfied. The worst response is used if the subject reports different responses for the left and right breasts.
Investigator Satisfaction With Breast Implants on a 5-Point Scale
Time frame: 5 years
Investigator satisfaction with each breast implant is assessed on the following 5-point scale: (Definitely Satisfied, Somewhat Satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, and Definitely Dissatisfied). Satisfaction is reported for Investigator's assessing satisfaction as definitely satisfied and somewhat satisfied. The worst response is used if the Investigator reports different responses for the left and right breasts.
Local Complications
Time frame: 5 years
Local complications are the cumulative complications occurring in at least 5% of subjects in 1 or more cohorts over the duration of the study. The Kaplan-Meier risk rate is presented.

Results and safety

Results posted to the registry on 11 Aug 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Augmentation	1,939	1,939
Revision-Augmentation	693	693
Reconstruction	751	751
Revision-Reconstruction	428	428

Primary outcome: Subject Satisfaction With Breast Implants on a 5-Point Scale

Time frame: 5 years. Number. Unit: Subjects

Measure	Augmentation n = 1929	Revision-Augmentation n = 688	Reconstruction n = 740	Revision-Reconstruction n = 419
Definitely Satisfied	1772	559	542	295
Somewhat Satisfied	119	87	145	89

Population analysed: Evaluable population: all enrolled subjects implanted with the NATRELLE 410 original style implants, who completed the 5 year follow-up visit, and had data at the time point.

Primary outcome: Investigator Satisfaction With Breast Implants on a 5-Point Scale

Time frame: 5 years. Number. Unit: Subjects

Measure	Augmentation n = 1922	Revision-Augmentation n = 689	Reconstruction n = 745	Revision-Reconstruction n = 418
Definitely Satisfied	1798	560	564	310
Somewhat Satisfied	97	83	141	83

Population analysed: Evaluable population: all enrolled subjects implanted with the NATRELLE 410 original style implants, who completed the 5 year follow-up visit, and had data at the time point.

Primary outcome: Local Complications

Time frame: 5 years. Number (95% Confidence Interval). Unit: Percentage of Subjects

Measure	Augmentation n = 1939	Revision-Augmentation n = 693	Reconstruction n = 751	Revision-Reconstruction n = 428
Capsular Contracture	3.27 (2.56 to 4.16)	6.33 (4.74 to 8.45)	6.48 (4.92 to 8.51)	7.29 (5.19 to 10.21)
Asymmetry	0.83 (0.51 to 1.35)	0.87 (0.39 to 1.93)	5.94 (4.46 to 7.90)	3.32 (1.98 to 5.54)

Population analysed: Evaluable population: all enrolled subjects implanted with the NATRELLE 410 original style implants who completed the 5 year follow-up visit.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Augmentation	0 of 1,939 (0%)	0 of 1,939 (0%)	Not reported
Revision-Augmentation	0 of 693 (0%)	0 of 693 (0%)	Not reported
Reconstruction	0 of 751 (0%)	0 of 751 (0%)	Not reported
Revision-Reconstruction	0 of 428 (0%)	0 of 428 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Breast Augmentation

RecruitingObservational study
The Study is an Observational Post-market Follow-up Program to Evaluate Long Term (5 Years) Safety of Mentor Breast Implants in Chinese Population
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Active, not recruiting
Memory Gel and Shape Combined Cohort
Primary Breast Augmentation, Primary Breast Reconstruction
Not yet recruiting
Effect of Adding Ultrasound-Guided PECS II Block to Standard Multimodal Analgesia in Breast Augmentation Surgery
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Active, not recruitingObservational study
Evaluation of the Performance and Safety of the Monobloc® - Silicone SoftOne® Breast Implants at 10 Years
Breast Augmentation, Breast Reconstruction
Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Allergan Medical

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Anatomically shaped silicone gel-filled breast implants in people with Breast Augmentation and Breast Reconstruction, run by Allergan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subject Satisfaction With Breast Implants on a 5-Point Scale (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01853605.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2015.